FDA WARNING_LETTER - Neobiosis, LLC - February 21, 2023

On June 5, 2024, the FDA issued a Warning Letter to Neobiosis, LLC, following an inspection from January 23 to February 21, 2023. The inspection revealed that Neobiosis manufactures and distributes unapproved drug and biological products derived from human amniotic fluid (Purified Amniotic Fluid - PAF) and umbilical cord (Wharton’s Jelly Cellular and Wharton’s Jelly Acellular) for allogeneic use.

The FDA determined these products are unapproved drugs and biological products because their intended uses, as evidenced by promotional materials (Facebook, YouTube, public interviews) for wound healing and orthopedic applications, classify them as such. They are not subject to an approved Biologics License Application (BLA) or an Investigational New Drug (IND) application. The umbilical cord products also fail to meet the homologous use and minimal manipulation criteria for HCT/Ps under 21 CFR 1271.10(a), thus requiring regulation as drugs and biological products.

Furthermore, the inspection identified significant Current Good Manufacturing Practice (CGMP) violations, rendering the products adulterated. Deficiencies include: - Failure to validate aseptic processes and sterilization for equipment (21 CFR 211.113(b)). - Inadequate environmental monitoring in aseptic processing areas (21 CFR 211.42(c)(10)(iv)). - Lack of